Mass Balance Study of [14C] LPM3770164 in Healthy Participants
ConditionHuntington Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorLuye Pharma Group Ltd.
About this trial
This is a phase 1, single-center, single-dose, open-label mass-balance study to evaluate radioactive recovery rate, radioactive PK characteristics, metabolite identification, and to observe the safety in healthy male subjects of \[14C\] LPM3770164.
Eligibility criteria
Qualifiers
Healthy adult Chinese males;
Age at informed consent: 18-45 years (including boundary value);
Body mass index (BMI) range of 19-26 kg/m2 (including the boundary value), and body weight of not less than 50 kg;
There is no plan to have children or donate sperm within 1 year after the participant signs the informed consent form and the participant voluntarily takes strict contraceptive measures within 1 year after signing the informed consent form and completing the trial;
Disqualifiers
Abnormal and clinically significant vital signs, physical examination, chest X-ray (anteroposterior), ophthalmic examination, anal digital examination and abdominal B ultrasound examination;
QTcF interval > 450 ms in men; or other abnormalities are clinically significant in the judgment of the investigator;
Abnormal tests of hepatitis B surface antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), treponema pallidum antibody and human immunodeficiency virus antibody are clinically significant at the investigator's discretion;
Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicine, food supplements within 4 weeks prior to screening;
Trial design
Treatments tested in this trial
- [14C] LPM3770164
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov